Cytomegalovirus, refractory, treatment (posttransplant): Oral: 400 mg twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Mild, moderate, or severe impairment: No dosage adjustment necessary.
End-stage renal disease, including patients on dialysis: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Mild or moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
(For additional information see "Maribavir: Pediatric drug information")
Cytomegalovirus, refractory, treatment (posttransplant): Children ≥12 years and Adolescents weighing ≥35 kg: Oral: 400 mg twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children ≥12 years and Adolescents:
Mild, moderate, or severe impairment: No dosage adjustment necessary.
End-stage renal disease, including patients on dialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Children ≥12 years and Adolescents:
Mild or moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Livtencity: 200 mg [contains brilliant blue fcf (fd&c blue #1)]
No
Oral: Administer with or without food.
Oral: May administer without regard to food.
Cytomegalovirus, refractory, treatment (posttransplant): Treatment of posttransplant cytomegalovirus infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet in adults and pediatric patients ≥12 years of age and weighing ≥35 kg.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Gastrointestinal: Diarrhea (19%), nausea (21%), vomiting (14%)
Hematologic & oncologic: Decreased hemoglobin (1% to 32%), decreased platelet count (5% to 18%)
Infection: Infection (23%; including cytomegalovirus disease)
Nervous system: Fatigue (12%), taste disorder (46%)
Renal: Increased serum creatinine (7% to 33%)
1% to 10%: Hematologic & oncologic: Decreased neutrophils (2% to 4%)
There are no contraindications listed in the manufacturer's labeling.
Other warnings/precautions:
• Virologic failure/relapse: Virologic failure due to resistance may occur during and after treatment with maribavir. Virologic relapse posttreatment usually occurs within 4 to 8 weeks after maribavir discontinuation. Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir. If a patient is not responding to treatment or relapses, check for maribavir resistance.
Substrate of CYP1A2 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
CarBAMazepine: May decrease the serum concentration of Maribavir. Management: Increase the dose of maribavir to 800 mg twice daily when combined with carbamazepine. Risk D: Consider therapy modification
CycloSPORINE (Systemic): Maribavir may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Maribavir. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Maribavir. Risk X: Avoid combination
Digoxin: Maribavir may increase the serum concentration of Digoxin. Risk C: Monitor therapy
Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Everolimus: Maribavir may increase the serum concentration of Everolimus. Risk C: Monitor therapy
Fosphenytoin-Phenytoin: May decrease the serum concentration of Maribavir. Management: Increase the dose of maribavir to 1,200 mg twice daily with concomitant use of fosphenytoin or phenytoin. Risk D: Consider therapy modification
Ganciclovir-Valganciclovir: Maribavir may diminish the therapeutic effect of Ganciclovir-Valganciclovir. Risk X: Avoid combination
Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
PHENobarbital: May decrease the serum concentration of Maribavir. Management: Increase the dose of maribavir to 1,200 mg twice daily with concomitant use of phenobarbital. Risk D: Consider therapy modification
Primidone: May decrease the serum concentration of Maribavir. Management: Increase the dose of maribavir to 1,200 mg twice daily with concomitant use of primidone. Risk D: Consider therapy modification
Rifabutin: May decrease the serum concentration of Maribavir. Risk X: Avoid combination
Rosuvastatin: Maribavir may increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Sirolimus Products: Maribavir may increase the serum concentration of Sirolimus Products. Risk C: Monitor therapy
St John's Wort: May decrease the serum concentration of Maribavir. Risk X: Avoid combination
Tacrolimus (Systemic): Maribavir may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
In initial studies, patients who could become pregnant were required to have a negative pregnancy test prior to treatment and use effective contraception during therapy (Maertens 2019; Papanicolaou 2019).
Based on ex vivo human placenta perfusion studies, maribavir is expected to cross the placenta (Faure Bardon 2020).
Adverse events were observed in some animal reproduction studies at doses lower than the equivalent recommended human dose. Pregnant patients were excluded from initial studies (Maertens 2019; Papanicolaou 2019).
It is not known if maribavir is present in breast milk.
The initial studies excluded patients who were breastfeeding (Maertens 2019; Papanicolaou 2019). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Cytomegalovirus DNA levels and assess for resistance as clinically appropriate; assess for resistance in patients not responding to treatment.
Maribavir is a benzimidazole riboside antiviral that competitively inhibits the protein kinase activity of human cytomegalovirus enzyme pUL97, resulting in inhibition of the phosphorylation of proteins.
Distribution: Vss: 27.3 L.
Protein binding: 98%.
Metabolism: Hepatic via CYP3A4 (major) and CYP1A2 (minor) to inactive metabolites.
Half-life elimination: Transplant patients: 4.32 hours.
Time to peak: 1 to 3 hours.
Excretion: Urine (61% [<2% unchanged]); feces (14% [5.7% unchanged]).
Tablets (Livtencity Oral)
200 mg (per each): $266.78
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